Trial Outcomes & Findings for An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis (NCT NCT00487539)

Last Updated: 2014-02-17

Results Overview

Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

1065 participants

Primary outcome timeframe

Baseline, Week 6

Results posted on

2014-02-17

Participant Flow

Participants were assigned to Placebo, Golimumab 100 mg-\>50 mg, Golimumab 200 mg-\>100 mg and Golimumab 400 mg-\>200 mg groups for dose selection. Efficacy results were reported for only newly enrolled participants assigned to Placebo, Golimumab 200 mg-\>100 mg and Golimumab 400 mg-\>200 mg groups after dose-selection as per planned analysis.

Participant milestones

Participant milestones
Measure	Placebo Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).	Golimumab 100 mg -> 50 mg Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.	Golimumab 200 mg -> 100 mg Golimumab 200 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 100 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).	Golimumab 400 mg -> 200 mg Golimumab 400 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 200 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
Overall Study STARTED	331	72	331	331
Overall Study COMPLETED	324	69	328	327
Overall Study NOT COMPLETED	7	3	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).	Golimumab 100 mg -> 50 mg Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.	Golimumab 200 mg -> 100 mg Golimumab 200 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 100 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).	Golimumab 400 mg -> 200 mg Golimumab 400 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 200 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
Overall Study Adverse Event	3	2	1	1
Overall Study Unsatisfactory therapeutic effect	1	0	0	1
Overall Study Other	3	1	2	2

Baseline Characteristics

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=331 Participants Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.	Golimumab 100 mg -> 50 mg n=72 Participants Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.	Golimumab 200 mg -> 100 mg n=331 Participants Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.	Golimumab 400 mg -> 200 mg n=331 Participants Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.	Total n=1065 Participants Total of all reporting groups
Age, Continuous	39 Years STANDARD_DEVIATION 13.04 • n=93 Participants	40.9 Years STANDARD_DEVIATION 12.19 • n=4 Participants	40 Years STANDARD_DEVIATION 13.54 • n=27 Participants	40.7 Years STANDARD_DEVIATION 13.75 • n=483 Participants	40 Years STANDARD_DEVIATION 13.37 • n=36 Participants
Sex: Female, Male Female	156 Participants n=93 Participants	32 Participants n=4 Participants	151 Participants n=27 Participants	130 Participants n=483 Participants	469 Participants n=36 Participants
Sex: Female, Male Male	175 Participants n=93 Participants	40 Participants n=4 Participants	180 Participants n=27 Participants	201 Participants n=483 Participants	596 Participants n=36 Participants

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.	Golimumab 200 mg -> 100 mg n=253 Participants Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.	Golimumab 400 mg -> 200 mg n=257 Participants Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
Number of Participants With Clinical Response at Week 6	76 Participants	129 Participants	141 Participants

SECONDARY outcome

Timeframe: Week 6

Population: Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.

Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.	Golimumab 200 mg -> 100 mg n=253 Participants Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.	Golimumab 400 mg -> 200 mg n=257 Participants Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
Number of Participants With Clinical Remission at Week 6	16 Participants	45 Participants	46 Participants

SECONDARY outcome

Timeframe: Week 6

Population: Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.

Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration).

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.	Golimumab 200 mg -> 100 mg n=253 Participants Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.	Golimumab 400 mg -> 200 mg n=257 Participants Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
Number of Participants With Mucosal Healing at Week 6	72 Participants	107 Participants	116 Participants

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

The IBDQ is used to measure disease specific quality of life on a 32 Likert-scaled items questionnaire. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function and social function with scores ranging from 10 to 70, 5 to 35, 12 to 84 and 5 to 35 respectively and the total score ranges from 32 to 224. Higher scores indicate better health related quality of life.

Outcome measures

Outcome measures
Measure	Placebo n=250 Participants Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.	Golimumab 200 mg -> 100 mg n=252 Participants Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.	Golimumab 400 mg -> 200 mg n=255 Participants Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6 Baseline	129.6 Units on a Scale Standard Deviation 32.61	131.7 Units on a Scale Standard Deviation 33.93	127.2 Units on a Scale Standard Deviation 33.90
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6 Change at Week 6	14.8 Units on a Scale Standard Deviation 31.25	27.0 Units on a Scale Standard Deviation 33.72	26.9 Units on a Scale Standard Deviation 34.28

Adverse Events

Placebo

Serious events: 20 serious events

Other events: 61 other events

Deaths: 0 deaths

Golimumab 100 mg -> 50 mg

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Golimumab 200 mg -> 100 mg

Serious events: 10 serious events

Other events: 54 other events

Deaths: 0 deaths

Golimumab 400 mg -> 200 mg

Serious events: 15 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=330 participants at risk Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.	Golimumab 100 mg -> 50 mg n=71 participants at risk Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.	Golimumab 200 mg -> 100 mg n=331 participants at risk Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.	Golimumab 400 mg -> 200 mg n=332 participants at risk Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
Blood and lymphatic system disorders Anaemia	1.8% 6/330 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	2.8% 2/71 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	2.4% 8/331 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	1.5% 5/332 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.
Gastrointestinal disorders Abdominal Pain	1.5% 5/330 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	1.4% 1/71 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.60% 2/331 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	2.1% 7/332 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.
Gastrointestinal disorders Colitis Ulcerative	2.1% 7/330 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	1.4% 1/71 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	1.2% 4/331 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.60% 2/332 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.
Gastrointestinal disorders Nausea	1.8% 6/330 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	1.4% 1/71 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.91% 3/331 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	3.6% 12/332 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.
General disorders Injection Site Erythema	0.00% 0/330 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	4.2% 3/71 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	1.5% 5/331 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	1.2% 4/332 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.
General disorders Pyrexia	2.1% 7/330 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	2.8% 2/71 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	1.5% 5/331 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	3.0% 10/332 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.
Infections and infestations Nasopharyngitis	3.6% 12/330 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	2.8% 2/71 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	3.9% 13/331 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	2.4% 8/332 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.
Infections and infestations Oral Herpes	0.30% 1/330 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	2.8% 2/71 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.60% 2/331 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.00% 0/332 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 7/330 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.00% 0/71 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.91% 3/331 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	1.8% 6/332 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.
Musculoskeletal and connective tissue disorders Back Pain	0.61% 2/330 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	2.8% 2/71 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.30% 1/331 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.30% 1/332 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.
Nervous system disorders Headache	5.2% 17/330 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	7.0% 5/71 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	3.3% 11/331 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	4.5% 15/332 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.
Psychiatric disorders Insomnia	0.91% 3/330 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	2.8% 2/71 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.30% 1/331 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.30% 1/332 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.
Respiratory, thoracic and mediastinal disorders Cough	2.7% 9/330 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.00% 0/71 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.91% 3/331 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.90% 3/332 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.
Skin and subcutaneous tissue disorders Rash	1.5% 5/330 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	2.8% 2/71 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.60% 2/331 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.	0.90% 3/332 • 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study. The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -\> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -\> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -\> 200 mg group.

Additional Information

Senior Director

Janssen Research & Development

Phone: 215-793-7540

Results disclosure agreements

Principal investigator is a sponsor employee 12 months after study ends, Sponsor will be provided with a copy of the materials at least 45 days prior to submission, with details of proposed date, journal or conference name of publication \& it will have 30 days post receipt to send a written request that the publication be delayed on the basis it exposes intellectual property that requires propriety protection but it will be only for 60 days after which Investigator will be free to publish. The participation of Sponsor will be acknowledged.
Publication restrictions are in place

Restriction type: OTHER